Kornimate/medical-research-clean huggingface dataset:
optic neuritis and ganglion cell layer

Conditions: Optic Neuritis

Summary: background and objectives: the recent expansion of the applications of optical coherence tomography (oct) demonstrated a higher correlation between the analysis of ganglion cells and visual function, in comparison with the analysis of the nerve fiber layer for several diseases of the optic nerve. atrophy of the ganglion cells tends to induce the visual function deficits. in the case of optic neuritis, inflammation of the optic nerve causes a deficit of visual function initially with low vision, color blindness and visual field. secondary atrophy of ganglion cell can result. the purpose of the study is to evaluate the correlation between the analysis of ganglion cells at the time of diagnosis of optic neuritis and the resulting visual acuity at 6 months and visual function (visual acuity, color vision and perimetry) 1 year regardless of treatment. a predictive effect could help predict the patient's clinical course and management of uncertainty and anxiety. materials and methods: an assessment at diagnosis and follow-ups at 6 months and 1 year with a measurement of best corrected visual acuity, a test color vision hrr (hardy-rand-rittler), an oct with analysis of ganglion cells and perimetry humphrey 30 -2 fast will be done. simple linear and logistic regressions will be used. results: we expect that there will be a significant association between atrophy of ganglion cells in the diagnosis and residual visual function after an episode of optic neuritis. we believe that the initial atrophy is associated with poorer visual prognosis. conclusion: a predictive effect could help to inform the patient about the evolution of the disease and provide early visual rehabilitation.


Eligibility criteria:
inclusion criteria: major and apt patients seen in consultation with diagnosis of optic neuritis exclusion criteria: * concomitant ophthalmic diseases * known macular pathology * amblyopia * glaucoma * history of an ophthalmic surgery * family history of hereditary optic neuropathy * pathological myopia (refractive error of 8 diopters or more). * known neurological disease other than multiple sclerosis. * habit * nutritional deficiency anorexia, restrictive gastrointestinal surgery. * active or former professional or recreational exposure * exposure to metals: lead, mercury, thallium * exposure to solvents: ethylene glycol, toluene, styrene, perchlorethylene; * prior poisoning: methanol, carbon dioxide. * usual or earlier medication * taking one or more drugs known to cause toxic optic neuropathy\* * listed available on demand

Keywords: optic neuritis ganglion cell layer
assessing the impact of acupuncture therapy on medical resident well-being: feasibility and acceptance

Conditions: Exhaustion; Syndrome

Summary: this feasibility study develops methods for larger-scale research, evaluating the acceptability and perceived impact of a group acupuncture and acupressure intervention, as well as suitability of a self-report instrument. during their weekly training program, eleven ob residents at nyu lutheran medical center will receive three sessions of auricular acupuncture therapy. (this resident population was previously anonymously surveyed and all expressed interest in participating in such a study). the professional quality of life scale (proqol) will be administered at 6 time points. a brief survey will also be given to assess participants' acceptance of the intervention as well as applicability of the proqol instrument. additional feasibility-related outcomes include protocol compliance/withdrawals, adverse events, and time taken to complete intervention and surveys.


Eligibility criteria:
inclusion criteria: * enrollment in nyu lutheran obstetrics \& gynecology residency program exclusion criteria: * women currently pregnant or attempting to conceive

Keywords: medical residents well-being stress/burnout in medical residents
removal of cytokines during extracorporeal circulation in cardiac surgery

Conditions: Coronary Artery Disease; Heart Valve Diseases

Summary: the aim of this study is to prove that using a cytosorb(tm) filter in the cardiopulmonary circuit attenuates the inflammatory response to extracorporeal circulation in patients undergoing cardiac surgery. the hypothesis is that removing cytokines from patients' blood by the cytosorb device significantly improves circulation and outcome in patients undergoing on-pump cardiac surgery.

cardiac surgery with cardiopulmonary bypass (cpb) induces an inflammatory response due to contact of patients' blood with foreign surfaces like tubes or the oxygenator, ischemic-reperfusion injury and surgical trauma. inflammation is modulated by cytokines, especially, interleukins. the extent of cytokine release is further related to the duration of bypass and the amount of operating field suction. this results in a systemic inflammatory response syndrome (sirs) with the risk of multiple organ dysfunction (mod). also in patients treated with extracorporeal membrane oxygenation (ecmo) an activation of the inflammation system is seen and accompanied with an increase of cytokine levels. the cytokine concentration correlates with the severity of the immune reaction and can be a predictor of the outcome of the patient. as severe sirs and mod significantly increase mortality, the attenuation of the inflammatory response is supposed to reduce morbidity and mortality after cardiac surgery. for adult cardiac surgery and patients who are treated with an extracorporal assist device, a tool for cytokine elimination and attenuation of the inflammatory response seems to be beneficial. in our study we are going to investigate if the use of the cytosorb device can improve the outcome of patients undergoing elective coronar artery bypass and heart valve surgery.

Eligibility criteria:
inclusion criteria: * undergoing elective coronar bypass and heart valve surgery * expected duration of bypass more than 120 min exclusion criteria: * age under 18 years of age * pregnancy * medication that interacts with the immune system (e.g. steroids, immune suppressors) * patients with diagnosed immunodeficiency (e.g. hiv/aids) * heparin induced thrombocytopenia type ii * patients that decline participation

Keywords: cytosorb(tm) cytokines inflammation cardiac surgery extracorporeal bypass
semen processing for icsi using swim-down and density gradient methods

Conditions: Infertility

Summary: the investigators evaluate the feedback of using swim down semen processing method during preparation for icsi and compare the results of pregnancy and embryos quality with the cases used density gradient method for their semen processing.

there is different semen processing method, in this study we compared the icsi output when the investigators used one method with higher separation method and minimum sperm stress or physical interface as swimming down using 100 % silica solution, with other more stressful procedure with high selection power as density gradient. the routine used method as density gradient (dg) includes about 30 min centrifugation at 1200 rpm, and more working steps with more handling procedures. according to many references the investigators can approve that it is method to be indicated with all cases particularly with those severely decreases semen number or motility. using 100 % silica solution for semen processing used for icsi, shews lesser centrifugation time and minimum processing procedures. as swimming down time is about 30 min followed by 5 min washing and finalized with other 3 minutes last wash. for that total interfering physical action is about 8 minutes compared with 30 min with dg method. in swimming down we are using the natural sperm behavior and own swimming power for separate itself from other seminal components. as well as only the one normally structure and motility direction the only can penetrate the interface surface of silica solution and swim inside higher density matrix using its speed and power.

Eligibility criteria:
inclusion criteria: all semen samples fresh or frozen that has, * cases have semen examination criteria fall within who 2010 standards of count * cases have semen examination criteria fall within who 2010 standards of motility * cases have semen examination criteria with all types of abnormal forms * cases produced more than 4 mature oocytes (m2) and more exclusion criteria: * cases have semen examination criteria with motility less than 5% * cases have semen examination criteria with count less than 1.0 million * cases with tese, tesa and epsa, both fresh and frozen * cases produced less than 4 mature oocytes (m2)

Keywords: icsi/ivf semen processing semen preparation swim down density gradient silica solution
3d instrumentation versus rotary instrumentation

Conditions: Postoperative Pain

Summary: enrollment of the patient after diagnosis, radiographic evaluation, and signing the informed consent. allocation of the patient to either intervention or control group. after anaesthesia and access cavity, the first root canal sample will be taken. endodontic treatment will be completed in one visit. the second root canal sample will be taken. patients will be asked to evaluate their postoperative pain level using vas scale at 6, 12, 24 hours, and daily up to 5 days. patients will record the number of analgesics if any taken.

after diagnosing the case as asymptomatic pulp necrosis and confirming that the patient conforms to all eligibility criteria, (r.s) will enroll the patient in the study. the operator will complete treatment of all cases in single visit as following: 1. anesthetizing the tooth using inferior alveolar nerve block technique 2. removal of caries and/or coronal restorations completely with sterile bur and rubber dam will be applied. 3. preparation of access cavity using another sterile round carbide bur size 3 and endo-z bur . 4. (r.s) will take the preinstrumentation root canal sample (s1) 5. confirming the patency of the root canals using stainless steel hand k-files size #10 and #15 . working length will be determined . 6. in the intervention group, (r.s) will perform mechanical preparation in a 3d manner using xp-endo shaper single file in an endodontic motor at a speed of 800 rpm and a torque of 1 ncm. 7. in the control group, mechanical preparation will be done using rotary irace files (#25/0.04, #30/0.04, and #40/0.04) at a speed of 600 rpm and a torque of 1.5 ncm. the canal will be irrigated and recapitulated after the use of each instrument. 8. edta gel will be used as a lubricant. the canals will be thoroughly irrigated using 3ml of 2.5% sodium hypochlorite. 9. the canal will then be dried by using sterile paper points and then flushed with 5 ml of 5% sodium thiosulfate to inactivate the naocl. the postinstrumentation sample (s2) will be taken from the canals. 10. master cones will be fitted to the working length and a radiograph will be taken to ensure proper length. 11. (r.s) will complete obturation using adseal resin-based root canal sealer .

Eligibility criteria:
inclusion criteria: 1. healthy adult patients. 2. age between 20-40 years old. 3. males \& females. 4. asymptomatic necrotic mandibular premolars with or without periapical radiolucency. 5. normal occlusal contact with the opposing teeth. 6. patients accepting to participate in the study. exclusion criteria: 1. medically compromised patients 2. pregnant women 3. if analgesics or antibiotics have been administrated by the patient during the past 12 hours preoperatively 4. patients reporting bruxism or clenching 5. teeth that shows: * association with acute periapical abscess and swelling * greater than grade i mobility or pocket depth greater than 5mm * no restorability
foot and ankle post-operative oedema management using geko™

Conditions: Surgery; Edema

Summary: the multicentre randomised geko™ foot and ankle trial will prospectively and systematically collect clinical data on patients randomised, on a 1:1 basis, to either standard care or standard care plus geko™ therapy to assess oedema management and patient outcomes during a follow-up period of up to three months post-surgery.

the geko™ device has a wide range of clinical applications including the post-operative management of oedema. although many short-term acute studies have been completed using the device, little clinical data has been collected on the effect of geko™ use in current standard care pathways for oedema management on patient outcomes during long term follow-up after surgery. this study is an open label, multi-centre prospective randomised study. the study patient population will be randomised on a 1:1 basis into two groups of 61 patients each. these groups are defined as group a patients who receive geko™ therapy and sc i.e. the intervention group and group b patients who receive standard care (sc) only i.e. no intervention. the participants will be assessed pre-surgery and up to 90 days post-surgery.

Eligibility criteria:
inclusion criteria: * aged ≥ 18 years * intact healthy skin at the site of geko™ device application. * patients that have been listed for forefoot and / or hindfoot surgery * patient understands and is willing to participate in the study and can comply with study procedures * patient is willing and able to give written informed consent exclusion criteria: * pregnant * use of any other neuro-modulation device. * trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve. * no response to geko™ therapy i.e. no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting * participation in any other clinical study that may interfere with the outcome of either study

Keywords: geko foot surgery ankle surgery oedema management post-operative oedema
a prospective, non-interventional study of roactemra/actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this prospective, observational study will evaluate the efficacy, safety and tolerability of roactemra/actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more conventional disease-modifying anti-rheumatic drugs. data will be collected from patients initiated on roactemra/actemra treatment according to the local label at baseline, weeks 4, 12 and 24, and at 3 and 6 months after the last dose of study drug.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 21 years of age * moderate to severe active rheumatoid arthritis (das28 \>/= 3.2) * inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (dmards) * initiated on roactemra/actemra treatment in accordance with the prescribing information exclusion criteria: * pregnant or lactating women * contra-indication to roactemra/actemra treatment according to the local labelling * previous treatment with tocilizumab * treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with roactemra/actemra * women of childbearing potential not using effective methods of contraception as defined by protocol
sense theatre intervention for children with autism spectrum disorder (asd)

Conditions: Autism Spectrum Disorder

Summary: the investigator's goal is to address the need for the development of social interventions for youth with autism in an innovative intervention, sense theatre. the intervention blends established behavioral strategies with theatre techniques that emphasize the involvement of peers, play and performance. the resulting synergy extends promising pilot studies in a randomized group experiment.

the investigator's goal is to address the need for the development of social interventions for youth with autism in an innovative intervention, sense theatre. the intervention blends established behavioral strategies with theatre techniques that emphasize the involvement of peers, play and performance. the resulting synergy extends promising pilot studies in a randomized group experiment. objectives: the purpose of the study is to evaluate and extend the impact of a peer-mediated, theatre-based intervention on children with asd with an emphasis on social functioning. the 10-session program incorporates theatrical approaches, trained typically developing peers and established behavioral strategies. previous studies using pre-post designs have reported improvement in several skills, such as face memory, theory of mind and social cognition. a primary objective of this investigation is to utilize a true experimental design while evaluating social ability across multiple levels of analysis including neuropsychological, cognitive, behavioral, and functional outcomes.

Eligibility criteria:
inclusion criteria: * children diagnosed with autism spectrum disorder with iq ≥ to 70. exclusion criteria: * iq ≤ 70, children with current aggression toward self or others.
oasis: peer support for t2dm in appalachia (peer coaches)

Conditions: Diabetes Mellitus, Type 2

Summary: the goal of this clinical trial is to compare the effects of peer coaching models in older adults with unmanaged type two diabetes. the main questions it aims to answer are: * are peer coaching models effective at promoting type 2 diabetes mellitus self-management? * if effective, which facets of the peer model are most effective? peer coaches will * undergo peer coach training. * reach out to peer participants on a weekly/biweekly time frame to discuss self-management and goal setting. * retain records of contact, topics discussed, and general notes on interactions. researchers will compare differences in the frequency of contact, as well as how peer coaches were matched to peer participants to see if efficacy of the intervention is altered between groups.

the older adults using social support to improve self-care (oasis) intervention is an asset-based approach, utilizing the unique social structure existing in kentucky's rural appalachian communities to address self-care behaviors as they relate to type 2 diabetes mellitus (t2dm) management. the intervention will be composed of two groups: peer coaches who have managed t2dm (hba1c \ 7.5%). peer coaches will undergo training prior to intervention initiation to develop coaching skills. peer participants will be linked to a peer coach in one of four ways: (1) self-select coach with contact once a week (2) self-selected coach with contact every 2 weeks (3) matched with peer coach with contact once a week (4) matched with peer coach with contact every 2 weeks. in addition to evaluating the effectiveness of a peer coaching model, the four groups will be evaluated allowing for a more detailed understanding of factors that influence self-care behaviors. stakeholders will also be engaged at three time points: prior to the intervention, study mid-point, and at study conclusion. at study conclusion, a small cohort of both peer participants and peer coaches will be invited to contribute to stakeholder group interviews. information exchange with stakeholders will aid in developing a robust understanding of influential factors and how to effectively promulgate the intervention.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 55 years * resident in rural kentucky * positive diagnosis of type 2 diabetes mellitus * hba1c less than 7.5 for peer coaches * passing score on cognitive assessment administered by study personnel * english speaking exclusion criteria: * age less than 55 years * not a resident of a rural kentucky county * cognitive impairment * non-english speaking

Keywords: appalachian region peer influence diabetes mellitus, type 2
iressa follow-up trial

Conditions: Lung Cancer; Breast Cancer

Summary: the purpose of this study is to assess the long-term safety profile and the secondary objective to estimate clinical benefit of zd1839 (gefitinib).


Eligibility criteria:
inclusion criteria: * provision of written informed consent to participate in the trial. * female or male aged 18 years and over. * patients with previously diagnosed cancer who have been treated with zd1839 in a parent zd1839 clinical trial and may benefit from continuation exclusion criteria: * known severe hypersensitivity to zd1839 * concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or st john's wort. * withdrawal from a parent zd1839 trial because of tumor progress

Keywords: lung cancer breast cancer
physical activity and cognitive function in older adults: a novel role for gpld1

Conditions: Aging; Cognitive Dysfunction

Summary: the investigators are conducting a cross-sectional, observational study to investigate whether plasma gpld1 concentrations are associated with higher cognitive function and better brain structure and function in two groups of older adults with high or low levels of physical activity.

this is a cross-sectional, observational study which will enroll up to 28 healthy, older adults (65-85 y, bmi 20-35 kg/m2), and stratify by current self-reported physical activity level (equal inactive vs. equal highly active). aim 1: investigate whether physical activity level is associated with gpld1. aim 2: investigate whether cognitive function and brain structure/function are associated with gpld1.

Eligibility criteria:
inclusion criteria: * ages 65-85 y (inclusive) * body mass index (bmi) of 20-35 kg/m2 (inclusive) * willing to have blood and data stored for future research use exclusion criteria: * history of clinically diagnosed diabetes (type 1 or 2) or a fasting blood glucose \>126 mg/dl * diagnosed alzheimer's disease, dementia, or related-brain diseases * chronic use of atypical antipsychotic or bipolar medications * initiation of novel pharmacotherapy agents (such as antidepressant, hypertension, or dyslipidemia) within the last 3 months * uncontrolled hypertension (blood pressure \>160 systolic or \>110 diastolic) * asthma that limits the ability to participate in moderate to vigorous physical activity or requiring systemic glucocorticoid administration * emphysema that limits the ability to participate in moderate to vigorous physical activity or requiring systemic glucocorticoid administration * current alcohol use exceeding 14 drinks per week in women, exceeding 21 drinks per week in men, having treatment for alcohol abuse in the last year, or having treatment for alcohol abuse more than 1 year ago (but with inability to refrain from alcohol in the past year) * use of illegal drugs or marijuana within 1-month of completing a screening visit; treatment for drug addiction in the 1-year or having treatment for drug addiction \>1-year ago, but with an inability to refrain from the drug of addiction in the 1-year * unwilling to abstain from illegal drugs and marijuana for the duration of the study * contraindication for mri (e.g., metal objects, claustrophobia, etc.) * psychotic mental illness (e.g., schizophrenia, bipolar, on-and- off use of anti-psychotic medication) * history of cardiovascular disease (or diseases of the heart, lungs, or blood) that limits participation in moderate to vigorous physical activity * history of liver, blood, kidney, thyroid or other diseases that limits moderate to vigorous physical activity at the time of enrollment * cancer that limits moderate to vigorous physical activity * treatment with systemic immunosuppressant medication * taking adrenergic stimulants (e.g., amphetamine) or adrenergic blockers (e.g., propanolol) that will alter metabolic rate * have plans to substantially alter their current level of physical activity over the next 1-month